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Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

NCT02498301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2023-02-15

No results posted yet for this study

Summary

The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel.

The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.

For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.

Conditions

  • Travelers' Diarrhea
  • Functional Bowel Disorders
  • Reactive Arthritis

Interventions

DRUG

Rifaximin

Rifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to

DRUG

Placebo

Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Ministry of Defence, United Kingdom

    collaborator OTHER_GOV

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Ramiro Gutierrez, MD · Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-10
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • United States
  • Kenya

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02498301 on ClinicalTrials.gov